PSUSA/00001125/202203 - periodic safety update report single assessment

Diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents

About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

• Active substance(s) in scope of the PSUSA procedure:
  Diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents
• Procedure number:
  PSUSA/00001125/202203
• Regulatory outcome:
  Maintenance

Documents

Diphtheria/tetanus/pertussis (acellular, component) vaccine (adsorbed), diphtheria/tetanus/pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents: List of nationally authorised medicinal pr...

Reference Number: EMA/759342/2022